Quality guidelines: impurities
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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The European Medicines Agency's scientific guidelines on impurities in drug products and drug substances help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Control of impurities of pharmacopoeial substances
- ICH Q3A (R2) Impurities in new drug substances
- ICH Q3B (R2) Impurities in new drug products
- ICH Q3C (R9) Residual solvents
- ICH Q3D Elemental impurities
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Setting specifications for related impurities in antibiotics